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Afrezza® is a man-made insulin that is breathed in through your lungs (inhaled) and is used to control high blood sugar in adults with type 1 or type 2 diabetes. Afrezza® is not for use in place of long-acting insulin. Afrezza® must be used with long-acting insulin in people who have type 1 diabetes mellitus. Afrezza® is not for use to treat diabetic ketoacidosis. Afrezza® is contraindicated in people with chronic lung disease such as asthma and COPD. It is not known if Afrezza® is safe and effective for use in people who smoke. Afrezza® is not for use in people who smoke or have recently stopped smoking (less than 6 months). It is not known if Afrezza® is safe and effective in children under 18 years of age.
Afrezza® is inhaled at the beginning of a meal. After you inhale Afrezza®, the insulin passes quickly through your lungs and into your bloodstream, where it begins reducing blood sugars.
Afrezza® is most active between 35–45 minutes and leaves the body between 1.5-3 hours.* Check with your healthcare provider on how frequently he or she wants you to monitor your blood sugar. You may need to take an additional dose of Afrezza® to achieve your optimal blood sugar control.
Afrezza® Blood Sugar Lowering Profile
Data from a randomized, controlled, six-treatment, crossover dose-response study compared Afrezza® with the rapid-acting insulin analog, lispro, in 30 patients with type 1 diabetes. Mean insulin effect (baseline-corrected glucose infusion rate) profile shown after administration of 4 and 12 Afrezza® unit doses in patients with type 1 diabetes. On average, the pharmacodynamic effect of Afrezza®, measured as area under the glucose infusion rate—time curve (AUC GIR)—increased linearly with doses up to 48 units. Intrapatient variability in AUC GIR and GIRmax is approximately 28% (95% CI 21-42%) and 27% (95% CI 20-40%), respectively.
*For the 4-unit and 12-unit cartridges, respectively.
Afrezza® is unique because it is the only ultra rapid-acting inhaled insulin available. It starts working quickly without the need for injections at mealtime. Once you breathe Afrezza® into your lungs using the inhaler, insulin appears in your bloodstream in less than 1 minute and it starts controlling blood sugar in about 12 minutes. Afrezza® leaves your body in 1.5-3 hours depending on the size of the dose you take.*
*for the 4-unit and 12-unit cartridges, respectively.
If you have type 1 diabetes, you will still need to take a long-acting insulin, or use an insulin pump for your basal needs depending on what you and your healthcare provider decide. Your healthcare provider may prescribe Afrezza® to treat mealtime spikes in blood sugar. If you are living with type 2 diabetes, your healthcare provider may consider adjustments to your other diabetes medications if they prescribe Afrezza®.
Afrezza® can be taken with oral diabetes medicines. Be sure to tell your healthcare provider about all other medicines and supplements you are taking because they can affect the way your insulin works.
Afrezza® is an ultra rapid-acting inhaled insulin used to control blood sugar in adults with type 1 or type 2 diabetes. It is not for people with certain types of lung disease (such as asthma or COPD) or who smoke. Do not use Afrezza® if you are allergic to regular human insulin or any of the ingredients in Afrezza®. Afrezza® is not for children under 18 years of age. Consult with your healthcare provider to determine if Afrezza® is right for you.
The most common side effects of Afrezza® include low blood sugar (hypoglycemia), cough, and sore throat or throat irritation.
Before prescribing Afrezza®, your healthcare provider will perform a breathing test to establish a baseline reading of your lung function. Your healthcare provider may test again at 6 months and once a year after that. As a reminder, if you have had or have asthma, COPD, or chronic lung disease, please tell your healthcare provider because patients with lung issues should not use Afrezza®. There is no proven link between Afrezza® and the risk of lung cancer.
Afrezza® contains insulin. Hypoglycemia (very low blood sugar) is the most common side effect with any insulin product. Severe hypoglycemia can cause seizures, may be life-threatening, or cause death. Talk to your healthcare provider to learn how to recognize the signs and symptoms of hypoglycemia and create an action plan in case of an episode of hypoglycemia. Signs and symptoms that may indicate low blood sugar include: dizziness or light-headedness, sweating, confusion, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability or mood change, and hunger.
You can get Afrezza® from any pharmacy. However, some pharmacies may not keep Afrezza® in stock and will need to order it. Once ordered, it will usually arrive at the pharmacy within 1–2 days.
Nationally, over 70% of patients covered by commercial insurance have access to Afrezza®, but everyone’s coverage is different. The best way to know if your plan covers Afrezza® is to call your insurance provider or contact one of our Patient Support Guides and they can help you understand your insurance coverage:
Every federally insured patient’s coverage is different. The best way to know your individual options is by calling your insurance provider or one of our Patient Support Guides. MannKind is committed to helping patients access Afrezza®. For more information, contact the MannKind Customer Experience Center:
If you have commercial insurance, you may be eligible for the Afrezza® Savings Card Program and pay as little as $15 per month for your prescription. Eligibility criteria and program limits apply. If you don’t have insurance or your insurance doesn’t cover Afrezza®, solutions may exist to help offset the cost. Contact the MannKind Customer Experience Center for more information:
Since Afrezza® is an inhaled powder, it is not uncommon to experience a cough at the beginning of your treatment. In the clinical studies, coughs were mild and typically declined with continued use after 1-4 weeks. As a suggestion, taking Afrezza® at room temperature and having a sip of water before and after inhalation may help. If you develop a persistent or recurring cough, or have breathing difficulties while using Afrezza®, contact your healthcare provider.
A small amount of powder residue in the mouthpiece or cartridge is normal. This does not affect your dose.
A small amount of powder residue in the mouthpiece or cartridge is normal. This does not affect your dose. Be sure to replace the inhaler every 15 days and continue to monitor your blood sugar.
Take Afrezza® exactly as your healthcare provider tells you to. Your healthcare provider should tell you how much Afrezza® to use and when to use it. Read the detailed Instructions for Use that comes with each carton/box/package of Afrezza®.
If you are still seeing high blood sugars after taking Afrezza®, it could be something related to inhalation technique, dose adjustment, or day-to-day variability of food and your body. You should consult with your healthcare provider. Dosing on Afrezza® is typically a two-step process with your healthcare provider: determining an initial dose and then adjusting as needed. During the first few days, it’s helpful to see how your body responds, and to talk to your healthcare provider to see if you need to adjust your dose of Afrezza® to achieve your optimal blood sugar control. Check with your healthcare provider on how frequently he or she wants you to monitor your blood sugar.
If you are sick, your insulin needs may change, so work with your healthcare provider to determine what type of dose adjustments would be right for you. In clinical trials, absorption of Afrezza® was not impacted by colds or allergies. Before you make any changes, consult with your healthcare provider.
Afrezza® is a mealtime insulin and is recommended to be taken at the beginning of the meal. Talk to your doctor about missed doses, and they will help you find an appropriate time to take Afrezza® based on your individual needs and goals.
While not in use, Afrezza® should be stored in the refrigerator just like any insulin. However, if you are traveling and don’t have access to a refrigerator, unopened blister cards or strips can be stored at room temperature for up to 10 days. After the foil is punctured, the cartridges can be stored at room temperature for up to three days. You should not put Afrezza® back into the refrigerator after it has been stored at room temperature. It should never be stored in the freezer. If you have questions about travelling with Afrezza®, contact the MannKind Customer Experience Center to speak to one of our Patient Support Guides:
Do not wash the Afrezza® inhaler. You can wipe the mouthpiece with a clean, dry cloth to remove moisture or lipstick.
Look on your box or on the foil wrapper to see when the expiration date is.
Afrezza® can cause serious side effects, including: Sudden lung problems (bronchospasms). Do not use Afrezza® if you have long-term (chronic) lung problems such as asthma or chronic obstructive pulmonary disease (COPD). Before starting Afrezza®, your healthcare provider will give you a breathing test to check how your lungs are working.
What is the most important information I should know about Afrezza®?
Afrezza® can cause serious side effects, including:
Sudden lung problems (bronchospasms). Do not use Afrezza® if you have long-term (chronic) lung problems such as asthma or chronic obstructive pulmonary disease (COPD). Before starting Afrezza®, your healthcare provider will give you a breathing test to check how your lungs are working.
Do not use Afrezza® if you:
Before using Afrezza®, tell your healthcare provider about all your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins or herbal supplements.
Before you start using Afrezza®, talk to your healthcare provider about low blood sugar and how to manage it.
While using Afrezza® do not:
Afrezza® may cause serious side effects that can lead to death, including:
See “What is the most important information I should know about Afrezza®?” at the top of this page.
Treatment with TZDs and Afrezza® may need to be changed or stopped by your healthcare provider if you have new or worse heart failure.
Get emergency medical help if you have:
• Trouble breathing, shortness of breath, fast heartbeat, swelling of your face, tongue, or throat, sweating, extreme drowsiness, dizziness, confusion.
The most common side effects of Afrezza® include:
These are not all the possible side effects of Afrezza®. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088).
Active ingredient: human insulin
Inactive ingredients: fumaryl diketopiperazine, polysorbate 80
General information about the safe and effective use of Afrezza®.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Afrezza® for a condition for which it was not prescribed. Do not give Afrezza® to other people, even if they have the same symptoms that you have. It may harm them.
This Medication Guide summarizes the most important information about Afrezza®. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Afrezza® that is written for health professionals.
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